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Thursday, October 16, 2014 - 9:45am - 10:45am
Test Automation

A Path through the Jungle: Validating a Test Automation System for the FDA

Test automation is difficult to get right. Working under FDA regulation presents its own challenges. Combining the two is a scary proposition because the FDA requires—and will scrutinize—the validation of any test automation used. Despite this, working in a regulated environment only magnifies the value of test automation. Aware that automation is a driver of quality and consistency, the FDA welcomes automated tests as part of an audit submission. The key to success is demonstrating quality in a way that the FDA recognizes. Chris Crapo and David Nelson lay out the road map to validation of a test automation system and highlight the critical thinking, planning, and types of maintenance that form the core of any successful validation strategy. By understanding the focal points of validation, you can set your project up for regulatory success while maintaining a lean, focused execution that drives results, not paperwork.

Chris Crapo, Boston Scientific Neuromodulation

A senior software engineer with Boston Scientific, Chris Crapo is currently the team lead for the test automation team. Chris has guided the in-house automation system from prototype to a full-featured system that supports unit, integration, and system testing for a number of Class III medical devices. His experience includes developing, testing, and validating software and tools in a regulated environment.

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David Nelson, Boston Scientific Neuromodulation

David Nelson is a principle software engineer with Boston Scientific and has been with them since 1998. David has worked on projects containing medical device software including implantable cardiac pacemakers and defibrillators, implantable stimulators, and external computers to program these devices. He has been involved in both the software development and verification/validation of these devices. David is also on the AAMI faculty and is an instructor for their validation class.

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